Keystone Heart Receives CE Mark for TriGuard Device

Keystone Heart, a developer of cerebral protection devices for interventional cardiology and cardiac surgery procedures, received CE mark for its TriGuard Cerebral Protection Device.

According to officials for the Caesarea, Israel-based company, TriGuard is the only device designed to cover all three aortic cerebral branches to minimize the risk of cerebral damage during transcatheter aortic valve teplacement (TAVR) and other cardiovascular procedures. It is the only system designed for placement through one of two femoral artery access ports. The TriGuard accommodates most anatomical variations of the aortic arch and uses a nitinol frame and mesh—”flexible and atraumatic, yet robust and sturdy,” according to the company.

Preserving cerebral function throughout medical procedures is a key component to procedural success and patient care.

“TriGuard is the most sophisticated cerebral embolic protection device currently available,” said Andreas Baumbach, M.D., consultant cardiologist at University Hospitals Bristol in the United Kingdom. “The device has the potential to become a routine preventive measure in TAVI and other cardiovascular procedures associated with embolic lesions. European approval of the TriGuard device is an important advancement in patient care.”

New scientific data presented at EuroPCR, demonstrated a significant reduction of new brain lesion volume during TAVR using TriGuard, compared with historical data on unprotected TAVR procedures. The clinical data showed that maximum total lesion volume was 95 percent smaller and average total lesion volume was 57 percent smaller when compared with historical references.

The medical community is witnessing heightened focus and scrutiny on cerebral injury concurrent with cardiovascular procedures – and research on possible preventative measures and devices to protect against brain injury has increased. Data from the PARTNER study show nearly twice as many strokes in the TAVR group compared with the surgical aortic valve replacement group at 30 days, the majority of strokes being peri-procedural and within the first two days. In addition, newer “next generation” TAVR devices have so far have apparently failed to reduce TAVR-related risk of stroke.

TriGuard is not yet commercially available in the United States.

Keystone’s technology focus is manufacturing cerebral protection devices to reduce the risk of stroke, neurocognitive decline and dementia caused by brain damage associated with cardiovascular procedures. The company is focused on protecting the brain from emboli to reduce the risk of brain infarcts during TAVR, surgical valve replacement, atrial fibrillation ablation and other structural heart procedures.

Clinical studies with the TriGuard currently are ongoing in Europe, Canada and Brazil.

Keystone Heart was founded in 2004.